Condition category
Cancer
Date applied
20/09/2005
Date assigned
01/12/2005
Last edited
29/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Jonathan Shamash

ORCID ID

Contact details

Department of Medical Oncology
7th Floor
Gloucester House
St Bartholomew's Hospital
London
EC1A 7BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00324298

Protocol/serial number

Version 4.1

Study information

Scientific title

Acronym

TE3

Study hypothesis

This study aims to ascertain whether administering the same total dose of bleomycin by a continuous 72-hour infusion over the first three days of chemotherapy results in lower lung toxicity than if administered conventionally as weekly bolus injections.

On 22/04/2010 this record was updated to coincide with protocol version 4.1 (previous protocol version 3 was registered); all changes can be found in the relevant fields:
1. The anticipated end date was changed from 31/12/2009 to 30/09/2010.
2. The target number of participants was also changed from 210 to 212.

On 15/02/2011 the anticipated end date was changed from 30/09/2010 to 30/03/2011.

Ethics approval

Northern and Yorkshire Multi-Centre REC, 10/07/2003

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

IGCCCG Good Prognosis Germ Cell Tumours

Intervention

Day 2, 8, 15 short (30 minute) versus day 1, 2, 3 long (72 hours) infusion bleomycin.
In addition to standard care for patients on chemotherapy, which includes biochemical and radiological evaluation of disease, patients will also undergo lung function testing and computed tomography (CT) to assess pulmonary toxicity.

Intervention type

Drug

Phase

Phase III

Drug names

Bleomycin

Primary outcome measures

Pulmonary toxicity, as confirmed by central radiological review of CT scans at 12 weeks after starting treatment

Secondary outcome measures

1. CT scan changes at 6 weeks
2. Quality of life
3. Changes in respiratory function tests
4. Treatment response
5. Progression-free and overall survival

Overall trial start date

08/07/2003

Overall trial end date

30/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 16 - 50 inclusive
2. Patients with proven good risk metastatic germ cell cancer of the testis
3. Patients eligible for treatment with bleomycin, etoposide and cisplatin
4. Patients who are able to understand their participation in the study and give written consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

212

Participant exclusion criteria

1. Patients who have had previous radiotherapy and/or chemotherapy
2. Patients with creatinine clearance less than 60 ml/min
3. Patients with a previous or concurrent second malignancy, except for basal cell skin cancer
4. Patients with any other major systemic illness
5. Impaired respiratory function i.e. shortness of breath on minimal exertion or hypoxia at rest, transfer coefficient for carbon monoxide (KCO), total lung capacity (TLC), forced expiratory volume in one second (FEV1) less than or equal to 60% predicted

Recruitment start date

08/07/2003

Recruitment end date

30/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medical Oncology
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

Barts and The London NHS Trust (UK)

Sponsor details

Joint R&D Department
Barts & The London NHS Trust
Rutland House
New Road
London
E1 2AX
United Kingdom
+44 (0)207 882 7260
gerry.leonard@bartsandthelondon.nhs.uk

Sponsor type

Government

Website

http://www.bartsandthelondon.nhs.uk

Funders

Funder type

Charity

Funder name

Orchid Cancer Appeal (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes